Helen has been with NDA since 2019 and her main responsibility is to ensure that NDA’s Quality Management System meets the requirements of our clients and conforms to relevant international standards and regulations. Helen has successfully developed the NDA Quality Management System and processes and helped numerous clients with Quality and Compliance projects throughout the different stages of the product life cycle.
Key Areas Of Expertise
- An executive-level leader in Quality and compliance operations for global corporations specializing in pharmaceuticals, biopharmaceuticals, medical devices, healthcare, and life sciences.
- Over 20 years of success developing and implementing global Quality Management Systems that drive an organizational focus on good manufacturing practices (GMP), good distribution practices (GDP), Quality system regulation medical devices and compliance to support business objectives.
- Strong expertise and experience in:
- Quality and compliance strategy development
- Quality due diligence, mergers & acquisitions
- Risk management & mitigation
- Quality system regulation medical devices
- Quality methods & systems
Helen was the Head of Quality & Regulatory Affairs (QRA) for North and South America at The Linde Group (2010-2015). Prior to that, as the Head of Global Quality Assurance at the Linde Healthcare from 2010-2015, she led the Quality strategy for four different segments: Hospital Care, Gas Therapy, Homecare, and Respiratory Services (including pharmaceuticals & medical devices).
She was also a member of the US Compressed Gas Association (CGA) and The European Industrial Gases Association (EIGA), representing the Linde group and Linde Healthcare in various working groups. Furthermore, she has been working as Vice President of Operational Excellence at Pharmadule and Senior Regional Manager / Quality, Regulatory, & Audit within Contract Manufacturing Organizations at Pfizer Pharmaceuticals.
Helen has a Master of Science in Pharmacy and a Master of Business Administration in Global Management.
- SEE ME, HELP ME, LEAD ME! How globalization of management will change your business (2007)